# United Sewing Automation, Inc.

- Location (FDA's records): Mount Airy, NC
- FDA decisions: 1 (2021–2021): 1 510(k) clearance
- Product codes: FXX (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- San-M Package Co., Ltd.: 1 (https://510kreport.com/company/san-m-package)
- 3M Healthcare: 1 (https://510kreport.com/company/3m-healthcare)

## Recent decisions
- K202697: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask (May 13, 2021)

Source page: https://510kreport.com/company/united-sewing-automation